Cleared Traditional

K872866 - STAND. CLEAR VINYL DISPOSABLE ECG ELECT...

K872866 is the FDA 510(k) clearance for STAND. CLEAR VINYL DISPOSABLE ECG ELECT... by Labeltape Meditect, Inc.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K872866 · Labeltape Meditect, Inc. · Cardiovascular device
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Jan 1988
Decision
191d
Days
Class 2
Risk

K872866 is an FDA 510(k) clearance for the STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(594 ADHE). Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Labeltape Meditect, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on January 28, 1988 after a review of 191 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Labeltape Meditect, Inc. devices

Submission Details

510(k) Number K872866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1987
Decision Date January 28, 1988
Days to Decision 191 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 125d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRX Electrode, Electrocardiograph

All 83
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K872866.
POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES
K885262 · Valleylab, Inc. · Jan 1989
BARD TAB ECG MONITORING ELECTRODE
K890103 · C.R. Bard, Inc. · Jan 1989
BARD MULTI-TAC ECG MONITORING ELECTRODE
K884064 · C.R. Bard, Inc. · Oct 1988
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A
K874421 · Hewlett-Packard Co. · Jan 1988
PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942D
K874422 · Hewlett-Packard Co. · Jan 1988
PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493E
K874423 · Hewlett-Packard Co. · Jan 1988